NCT01601483

Efficacy and Safety Study of MC-1101 1% TID in the Treatment of Nonexudative Age-Related Macular Degeneration

Phase II/III Study of the Efficacy and Safety of Macuclear MC-1101 1% TID in the Treatment of Nonexudative Age-Related Macular Degeneration

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: MacuCLEAR, Inc. · Industry
• Sex: All
• Age: 50 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase II/III vehicle controlled, double masked, single center study. A single eye of 60 individuals with mild to moderate nonexudative Age-Related Macular Degeneration (AMD) will be randomly assigned to receive either topical 1% MC-1101 or a vehicle control over 2 years. The study design will assess the efficacy, safety, and tolerability of MC-1101 for these patients. An analysis of the primary and secondary endpoints will be conducted when all subjects have completed 12, 18 and 24 months.

Conditions

• Nonexudative Age Related Macular Degeneration

Interventions

Type	Name	Description
DRUG	MC-1101	1% Ophthalmic Solution TID
DRUG	MC-1101 Vehicle	Ophthalmic solution, TID

Timeline

• Start date: 2012-10-01
• Primary completion: 2013-03-01
• Completion: 2013-03-01
• First posted: 2012-05-18
• Last updated: 2014-04-28

Locations

1 site across 1 country: United States